Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2919128

FEI Number

2919128

Entity Name

HAND BIOMECHANICS LAB, INC.

City/State/Country

SACRAMENTO, CA, US

Establishment Address

77 Scripps Dr Ste 104, SACRAMENTO, CA 95825, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HAND BIOMECHANICS LAB, INC. (Owner Number: 2919128)

Owner / Operator Contact Address

77 SCRIPPS DR., SUITE 104, --, Sacramento, CA 95825, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252020

PMA Number

N/A

All Registered Proprietary Names

PIP Fix Agee PIP Fix PIP Fix PIP Fix® External Fixation System Disposable Blade Assembly ECTR Disposable Blade Assembly Endoscopic Carpal Tunnel Release Blade Assembly TurnKey FCS Agee TurnKey FCS® External Fixation System Agee TurnKey FCS® TurnKey FCS® External Fixation System TurnKey FCS® AGEE-WRISTJACK SYSTEM-STERILE Agee WristJack® External Fixation System, Sterile Agee WristJack® External Fixation System Agee WristJack® Agee-WristJack® Fracture Reduction System, Sterile WristJack® TunnelVision System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2019-01-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-11-15
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2008-02-06
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2008-02-06
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-02-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-02-09
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2026-02-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HAND BIOMECHANICS LAB, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number	Establishment Name	Location
3010860227	VIRAK ORTHOPEDICS LLC	Madison, NJ, US
9680825	ORTHOFIX SRL	BUSSOLENGO Verona, IT
3038503932	Smith & Nephew, Inc.	Memphis, TN, US
1720929	ISOMEDIX OPERATIONS INC.	Sandy, UT, US
3011500362	SPITREX ORTHOPEDICS SWITZERLAND SA	Le Locle Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2919128. Last updated year: 2026. Please use registration number 2919128 when referencing this establishment in official correspondence.